This study was conducted to obtain safety and immunogenicity data after a booster dose of Zoster Vaccine, Live administered ≥10 years following an initial dose. This information was compared to similar information obtained after Zoster Vaccine, Live administration to age-matched and younger participants who received their first dose of Zoster Vaccine, Live. The study was designed to determine: 1) whether a booster dose of Zoster Vaccine, Live in participants ≥70 years of age induces an antibody response that is noninferior to that of a first dose of Zoster Vaccine, Live in participants matched for age; 2) whether a booster dose of Zoster Vaccine, Live induces an acceptable rise in the level of varicella-zoster virus (VZV) antibodies.

VZV antibody titers were determined by gpELISA. The GMFR measures the rise in VZV antibodies from Day 1 (Baseline) to Week 6 postvaccination.

Secondary Outcome Measures:

Number of Participants Reporting One or More Adverse Experiences [ Time Frame: Up to 42 days postvaccination ] [ Designated as safety issue: Yes ]

An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience. A serious adverse experience is any AE that results in death, is life threatening, results in persistent disability/incapacity, results in or prolongs existing inpatient hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is another important medical event that may jeopardize the participant and may require medical or surgical intervention. Vaccine-related AEs were those assessed by the investigator as definitely, probably, or possibly related to vaccine administration. This outcome measure applies only to AEs collected after vaccination in Part 1 of the current study.

Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004 NCT00007501)

Biological: Zoster Vaccine, Live

Single approximately 0.65-mL subcutaneous injection of Zoster Vaccine, Live on Day 1 of the study

Other Names:

V211

ZOSTAVAX™

Experimental: Group 2: First Dose Participants ≥70 years of age

Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age

Biological: Zoster Vaccine, Live

Single approximately 0.65-mL subcutaneous injection of Zoster Vaccine, Live on Day 1 of the study

Other Names:

V211

ZOSTAVAX™

Experimental: Group 3: First Dose Participants ≥60 and <70 years of age

Herpes zoster history-negative participants ≥60 and <70 years of age who have never received Zoster Vaccine, Live

Biological: Zoster Vaccine, Live

Single approximately 0.65-mL subcutaneous injection of Zoster Vaccine, Live on Day 1 of the study

Other Names:

V211

ZOSTAVAX™

Experimental: Group 4: First Dose Participants ≥50 and <60 years of age

Herpes zoster history-negative participants ≥50 and <60 years of age who have never received Zoster Vaccine, Live

Biological: Zoster Vaccine, Live

Single approximately 0.65-mL subcutaneous injection of Zoster Vaccine, Live on Day 1 of the study

Other Names:

V211

ZOSTAVAX™

Detailed Description:

All participants were followed for one year after completion of the 42-day post-vaccination period while Groups 1 and 2 were followed for a total of three years.

Eligibility

Ages Eligible for Study:

50 Years and older (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

All Groups:

Must not have a fever of ≥100.4° F on the day of vaccination

Any underlying chronic illness must be in stable condition

History of varicella or residence in a VZV-endemic area for ≥30 years

Group 1:

70 years of age or older

Took part in the Shingles Prevention Study (SPS) (V211-004, NCT00007501) and received a single dose of Zoster Vaccine, Live ≥10 years prior to enrollment in this study

Group 2:

70 years of age or older

Group 3:

60 to 69 years of age

Group 4:

50 to 59 years of age

Exclusion Criteria:

All Groups:

History of hypersensitivity reaction to any vaccine component or an anaphylactic/anaphylactoid reaction to neomycin

Prior history of herpes zoster

Pregnant or breast-feeding, or expecting to conceive within the duration of the study

Has been treated with immunoglobulin or any blood products, other than autologous (self-donated) blood transfusion, in the 5 months prior to vaccination

Received any other vaccine within 4 weeks prevaccination

On immunosuppressive therapy

Has known or suspected immune dysfunction

Is taking any non-topical antiviral therapy with activity against herpesviruses, including, but not limited to acyclovir, famciclovir, valacyclovir, and ganciclovir.

Groups 2, 3, and 4:

Has previously received any varicella or zoster vaccine

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01245751